510(k) · Cleared
ClearedHand STC, Model 60MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Niti Medical Technologies, Ltd. · GDW Staple, Implantable
Cleared on Oct 19, 2004 as substantially equivalent to K892927 (ETHICON, Inc., 1989) and 3 other predicates after a 35-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Oct 19, 2004
- Review
- 35 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K843603 (1984). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK843603 Auto Suture Poly Gia Surgical StaplerUnited States Surgical, A Division of Tyco Healthc · 1984
- This deviceK042492 Hand STC, Model 60MMNiti Medical Technologies, Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843603 | Auto Suture Poly Gia Surgical Stapler | United States Surgical, A Division of Tyco Healthc | 1984 | — |
| 0 (this device) | K042492 | Hand STC, Model 60MM | Niti Medical Technologies, Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GDW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GDW device
- #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.1 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K892927 | Proximate Linear Cutter Thick Tissue Inst.Summary page 2…sion of General and Restorative Devices. Predicate Devices: • ProximateTM TVC55 Linear Cutter and Stapler (Ethicon Endo- Surgery, Inc. USA) cleared under K892927. * Multifire GIA 60 stapler (United States Surgical Cooperation, UAS) cleared under K843603. * Universal Endo… | 1989 |
| * | K843603 | Auto Suture Poly Gia Surgical StaplerSummary page 2…Stapler (Ethicon Endo- Surgery, Inc. USA) cleared under K892927. * Multifire GIA 60 stapler (United States Surgical Cooperation, UAS) cleared under K843603. * Universal Endo GIA 60 (United States Surgical Cooperation, UAS) originally cleared under K892233 and K900129.… | 1984 |
| * | K892233 | Auto Suture (R) Endoscopic Gia (TM) Surgical StaplerSummary page 2…States Surgical Cooperation, UAS) cleared under K843603. * Universal Endo GIA 60 (United States Surgical Cooperation, UAS) originally cleared under K892233 and K900129. Performance Standards: No performance standards have been established for such device under Section 514… | 1989 |
| * | K900129 | Modified Auto Suture Endoscopic Gia Surg. Stapler*Summary page 2…cal Cooperation, UAS) cleared under K843603. * Universal Endo GIA 60 (United States Surgical Cooperation, UAS) originally cleared under K892233 and K900129. Performance Standards: No performance standards have been established for such device under Section 514 of the Fede… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K892927.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GDW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GDW
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GDW
3in 2025
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GDW
11,905in 2025
MAUDE reports naming product code GDW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 56 | 9 | 2,401 |
| 2008 | 7 | 57 | 0 | 2,380 |
| 2009 | 13 | 27 | 22 | 4,014 |
| 2010 | 10 | 39 | 2 | 3,768 |
| 2011 | 11 | 49 | 9 | 3,826 |
| 2012 | 9 | 45 | 11 (1) | 3,717 |
| 2013 | 13 | 49 | 1 | 3,777 |
| 2014 | 15 | 63 | 0 | 4,784 |
| 2015 | 8 | 111 | 6 | 4,899 |
| 2016 | 11 | 96 | 2 | 5,106 |
| 2017 | 13 | 103 | 3 | 11,643 |
| 2018 | 7 | 90 | 3 | 14,914 |
| 2019 | 12 | 205 | 4 (4) | 16,600 |
| 2020 | 10 | 88 | 11 | 12,332 |
| 2021 | 9 | 233 | 0 | 13,015 |
| 2022 | 7 | 89 | 0 | 13,605 |
| 2023 | 4 | 267 | 1 | 14,623 |
| 2024 | 2 | — | 0 | 13,280 |
| 2025 | 3 | 111 | 3 | 11,905 |
| 2026 | 3 | 141 | 0 | — |
What is it indicated for?
The NiTi HandSTC has applications throughout the alimentary tract in surgeries for resection, transaction, and the creation of anastomoses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042492 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042492: Hand STC, Model 60MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042492
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026